Events

Recall of Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis Fistula Pack 5FME

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Medical Care Packs Australia.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01167-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01167-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    It has been reported that the needle cannula of the a.V fistula set for haemodialysis had separated from the needle hub and remained in the patient’s vein when attempting to remove the needle following the completion of the dialysis treatment. although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient’s vein.There have been no reports of patient injury as a result of this issue.
  • Action
    Fresenius is advising users to quarantine and destroy any affected units in stock. This action has been closed-out on 26/08/2016.

Device

Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis F...
  • Model / Serial
    Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis Fistula Pack 5FME Material Number: AU850005FME Lot Number: 53818, 54477, 54881, 55299,57807,58263 and 58667Containing Terumo Material Number: AVFE1525CLFGTerumo Lot Numbers: 14071418,1410415,15012817,45051111Safety AVF Needle - Fixed WingFME Material Number: AU00086FME Lot Number: 14071418,14101415,1411011,1505111Terumo Material Number: AVFE1525CLFGARTG Numbers: 121471,130567
  • Manufacturer
    Fresenius Medical Care Packs Australia

Manufacturer

Fresenius Medical Care Packs Australia